Tissium Sa: In Situ Polymerizing Peripheral Nerve Repair Device
COAPTIUM CONNECT Recall Summary TISSIUM SA is recalling the COAPTIUM CONNECT nerve repair device because the shelf life listed on the package (36 months) hasn't been proven accurate by real-time data; the company is relabeling all devices to show a shorter shelf life of 26 months instead. Devices used after their validated shelf life may break during surgery, potentially requiring additional surgery to repair or replace them. The device was distributed nationwide, primarily in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
- Recalling firm
- TISSIUM SA
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Reason
- Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1db50c2f-ece1-4bf3-b2e3-aa70904540fa